To establish the effect of oral inulin supplementation on continuous glucose monitoring (CGM) metrics and immunological parameters in adults with type 1 diabetes.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To establish the effect of once daily inulin supplementation on time in range
in adults with type 1 diabetes.
Secondary outcome
To establish the effect of once daily inulin supplementation on:
- Other CGM metrics (time above range, time below range and glucose variability)
- Quality of Life and abdominal complaints, as assessed by validated
questionnaires
- Number of hypglycaemic episodes (assessed by CGM)
- Gut inflammation (fecal calprotectin, IgA)
- Systemic inflammation/autoimmunity (using a cytokine panel, CRP, leucocytes
and autoantibodies)
- Gut microbiome composition (using shotgun metagenomic sequencing)
- Residual beta cell function (post meal urine C-peptide/creatinine levels)
- Insulin resistance (insulin dose/kg, HbA1c, quantified with formula of
Januszewski et al (17).
Background summary
Type 1 diabetes is a complex autoimmune disease involving genetic and
environmental factors with an increasing worldwide incidence. Despite mounting
pathophysiological insights, exogenous insulin replacement is to date the sole
available treatment, rendering type 1 diabetes a disease with a vast array of
complications and a reduced life expectancy of 24 years in the global
population and ~11 years in high-income countries. With new technologies (such
as insulin pumps), blood sugar levels have improved for many people with type 1
diabetes, but there is still significant room for improvement. Therefore, it is
essential to find an additional treatment that can help maintain glycaemic
control more easily within the target range (time in range). We focus on a safe
and easy-to-take treatment involving a promising dietary fiber .Fermentable
fibres such as inulin show evident glucose lowering effects in type 2 diabetes
and have well-described immunological and metabolic effects. However, no
clinical trial assessing immunological and glycaemic effects of inulin in
adults with type 1 diabetes has been performed.
Study objective
To establish the effect of oral inulin supplementation on continuous glucose
monitoring (CGM) metrics and immunological parameters in adults with type 1
diabetes.
Study design
A double-blind, randomized, placebo-controlled trial with 2 arms (n= 38 per
arm). The study duration is 12 weeks
Intervention
• Group 1. The people in this group will receive 10 grams of inulin per day in
a sachet for 12 weeks.
• Group 2. The people in this group will receive a placebo that looks the same
as the active medication for 12 weeks. This is maltodextrin, a safe substance
commonly used as a placebo
Study burden and risks
Since inulin is a safe, generally available and widely used food supplement, we
consider the risk of this trial to be negligible. If any, mild
gastro-intestinal complaints such as bloating or flatulence are expected.
The patient will complete various questionnaires, keep a food diary, and
collect urine and stool samples prior to the research visit. During the
research visit, we will take fasting blood samples, which slightly increases
the risk of a hypoglycemic episode; however, this risk will largely be
mitigated as all participants will wear a continuous glucose monitor. In
addition, we will calculate BMI, measure waist circumference, and assess blood
pressure. The questionnaires will inquire about quality of life and any
gastrointestinal complaints. If possible, the study visit will be combined with
a regular appointment with their own healthcare provider.
Overall, we believe that this study has a low risk and a low burden.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Males or females, age 18-70 years
- A diagnosis of type 1 diabetes, as made by their primary clinician
- A time in range of <80% in the last four weeks before screening
Exclusion criteria
- Use of any fibre supplementation (within the last month before screening or
ongoing)
- Use of antibiotics in the lasts three months before screening or during study
period
- Active infection during the study visit
- Inability or unwillingness to donate feces or urine.
- Illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past
three months or use during the study period.
- Inability or unwillingness to provide informed consent.
- Absence of a large bowel (ie colostomy)
- Active inflammatory bowel disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88145.018.25 |
| CCMO | NL88145.018.24 |